H&P Povidone Iodine Recall Affects Swabsticks, Gels and Solutions

A potential risk of infection has led to the recall of Povidone Iodine swabsticks, surgery prep solutions and prep gels by the same company that recalled millions of contaminated alcohol prep products earlier this year. 

The Povidone Iodine prep product recall was announced by the FDA and H&P Industries on August 24, after the FDA forced the company to remove the products from the market because they were manufactured without procedures designed to ensure they were free of microbial contamination. The recalled iodine products are used for surgery preparation.

Microbial contamination of surgery prep products could lead to patients contracting a serious and potentially life-threatening infection, which can be especially risky for individuals recovering from major surgery or if a patient is elderly, a child or has a compromised immune system.

Earlier this year, millions of Triad alcohol prep pads, swabs and wipes manufactured by H&P were recalled due to contamination by Bacillus cereus bacteria, which has been blamed for at least eight deaths.

The latest recall affects all lots of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel. In its press release announcing the recall, H&P stated that there have been no reports of infections and no contamination of the products has been found during testing.

The recall was part of a consent decree between H&P and the FDA stemming from the Triad alcohol prep pads recall, which was entered into the U.S. District Court for the Eastern District of Wisconsin, where H&P is based, on June 13. The same consent decree prevents H&P from manufacturing new products until it meets a number of requirements set by the FDA to increase the safety of its products.

Dozens of Triad alcohol prep pad lawsuits have been filed against H&P Industries, including several wrongful death lawsuits brought by family members who say that loved ones died due to Triad wipe infections.